Safety and Efficacy Study of Topical DLQ01 in the Treatment of Androgenetic Alopecia (AGA) in Men

A Proof-Of-Concept Phase 1b/2a Randomized, Vehicle, and Comparator-Controlled Study of Topical DLQ01 to Assess the Safety and Efficacy in the Treatment of Androgenetic Alopecia (AGA) in Men

The goal of this study is to measure the safety, tolerability, and the hair growth response to topical DLQ01 solutions in comparison to the vehicle and a comparator solution in 120 males with Androgenetic Alopecia.

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Drug: prostaglandin F2a analogue in vehicle solution high dose; Drug: prostaglandin F2a analogue in vehicle solution low dose; Drug: active ingredient-free vehicle solution to DLQ01; Drug: Minoxidil 5% Topical Solution

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Betsy Hughes-Formella, PhD; Phone Number: +49 6221 4353; Email: info@dermaliq.com

Study Locations

• Australia
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Dr Rodney Sinclair Pty Ltd,
      • Contact: Jo Anne Yeo
    • Pascoe Vale South, Victoria, Australia, 3044
      • Dr Rodney Sinclair Pty Ltd,
      • Contact: Jo Anne Yeo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Males with active AGA on the vertex area of the scalp consistent with Norwood-Hamilton Grades of IIIv through V, excluding IIIa, IVa, and Va grades.
• Willing to maintain the same hair style, approximate length, and hair colour throughout the duration of the study as documented in the global photograph at Day -2 of baseline.
• Willing to have target areas shaved and to have temporary dot tattoos placed on their scalp.
• Willing to comply with the study instructions and return to the site for required visits.
• Must be willing and able to communicate and participate in the entire study and willing to use an electronic diary to record investigational product dosing.
• Must provide written informed consent.

Exclusion Criteria:

• Participants with other type of alopecia other than AGA or any other concomitant skin or systemic disorder involving the scalp area.
• Participants with sensitive, irritated, or abraded scalp area.
• Participants who have undergone hair transplants or have had scalp reductions.
• Concurrent treatments or interventions that could affect interpretation of study data, prior to or during the study, as specified in the protocol
• Current evidence of another ongoing or acute relevant cutaneous infection, active systemic infection, or other significant skin conditions.
• History of relevant sensitivity to any of the study products, or components thereof, or a history of drug or other allergy that contraindicates study participation.
• Known allergy or sensitivity to tattoo ink.
• Participant with relevant active or prior history of malignancies.
• Participants with relevant cardiovascular disease including ischemic heart disease, cardiac arrhythmias, or congestive heart disease.
• History of any relevant alcoholism, substance or drug abuse-related disorders in the past year or a positive toxicology screening panel, or alcohol breath test at Screening.
• Clinically significant abnormal biochemistry, haematology or urinalysis values.
• Any other relevant serious illness or medical, physical, or psychiatric condition(s) that, could interfere with full participation in the study, pose a significant risk to the participant; or interfere with interpretation of study data.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DLQ01 high dose; Twice daily application of DLQ01 high dose cutaneous solution in 30 subjects	Drug: prostaglandin F2a analogue in vehicle solution high dose; Topical treatment for 24 weeks; Other Names: DLQ01 high dose
Experimental: DLQ01 low dose; Twice daily application of DLQ01 low dose cutaneous solution in 30 subjects	Drug: prostaglandin F2a analogue in vehicle solution low dose; Topical treatment for 24 weeks; Other Names: DLQ01 low dose
Placebo Comparator: active ingredient-free vehicle solution to DLQ01; Twice daily application of DLQ01 vehicle cutaneous solution in 30 subjects	Drug: active ingredient-free vehicle solution to DLQ01; Topical treatment for 24 weeks; Other Names: DLQ01 vehicle
Active Comparator: Minoxidil Solution 5%; Twice daily application of the comparator cutaneous solution in 30 subjects	Drug: Minoxidil 5% Topical Solution; Topical treatment for 24 weeks; Other Names: Regaine®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TAHC (total, terminal, and vellus)	Change from baseline in total, terminal, and vellus target area hair counts (TAHC) using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit	28 weeks
Cumulative hair thickness density (mm/cm2)	Change in cumulative hair thickness density using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit.	28 weeks
Anagen/telogen ratio	Change in anagen/telogen ratios using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit.	28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator global assessment (IGA) using a 7-point ordinal scale compared to baseline	Investigator assessment of the participant´s scalp hair growth compared to baseline using the following 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3) compared to baseline at 4, 12, 16, and 24 weeks of treatment, and at the follow-up visit	28 weeks
Frequency of scores for cutaneous reactions in the treated area through study day 194	Investigator assessment of cutaneous reactions such as erythema, oedema, glazing with fissures, vesicles, or papules, by grading with a clinical 5-point scale: no irritation (0), mild (1), moderate (2), severe (3), and very severe (4) at each visit through study day 194	28 weeks
Frequency of scores for pigmentation changes compared to non-treated area of scalp and hair through study day 194	Investigator assessment of pigmentation changes compared to non-treated area of scalp and hair by grading with a clinical 4-point scale: no difference (0), slight difference, <25% (1), moderate difference, <50 to 75% (2), significantly darker/lighter, <75 to 100% (3) at each visit through study day 194	28 weeks
Number of participants with clinically significant abnormal laboratory test results	Collection of safety blood at screening, after 24 weeks of treatment, and at follow-up	28 weeks
Number of participants with clinically significant abnormal heart rate	Collection of heart rate at screening, baseline, and after 4, 16, and 24 weeks of treatment, and at follow-up	28 weeks
Number of participants with clinically significant abnormal blood pressure	Collection of blood pressure at screening, baseline, and after 4, 16, and 24 weeks of treatment, and at follow-up	28 weeks
Number of participants with clinically significant abnormal ECG readings	Collection of 12-lead ECG at screening, and after 4, 12, 16, and 24 weeks of treatment, and at follow-up	28 weeks
Plasma concentrations of DLQ01	Blood samples for evaluation of plasma concentrations of active ingredient and novel excipient will be taken at baseline (predose) and after 4, 12 and 24 weeks of treatment	24 weeks

Collaborators and Investigators

• Sponsor: Dermaliq Therapeutics, Inc.
• Investigators: Study Director: Betsy Hughes-Formella, PhD, Dermaliq Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Actual): March 28, 2024
• Study Completion (Actual): March 28, 2024

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Physiological Effects of Drugs; Antihypertensive Agents; Vasodilator Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Pharmaceutical Solutions; Minoxidil; Dinoprost; Dinoprost tromethamine
• Other Study ID Numbers: DLQ01-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No